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Question: Should expired/outdated medications or medications issued to patients and
then returned to a pharmacy or elsewhere, or were given to health professionals as free
samples be used in short-term healthcare missions?
Participants in discussion
Background (perspective)
Peter Yorgin, MD
Team leader and participant for 9
Initiator and primary author
healthcare mission trips to Ukraine, China
and Mexico, Academic physician at Loma
Linda University, Harvest Christian
Fellowship
Noel Johnson, DO
Medical Team Leader
Best Practices Group, September 18, 2008
Pasadena, CA
Arnold Gorske, MD
Dan O’Neil, MD
Eithne Keegan, RN
Glenn Schwartz, Ph.D.
Grace Tazelaar, MSN, RN
Janet Ishida, PT
Lori Bajkiewicz
Michael Soderling, MD
Peter Yorgin, MD
Why is this important? This is an issue of trust, safety and perceptions.
Consensus Statement
1. Short-term healthcare mission teams should not dispense expired
medications or medications issued to patients and then returned to a
pharmacy or elsewhere, or medications that were given to health
professionals as free samples.
2. Primary rationale
a. WHO Guidelines for Drug Donation WHO/EDM/PAR/99.4 (appended)
http://www.euro.who.int/document/eha/par_donate_guidelines.pdf
Biblical concepts involved
Deception
Psalm 12:2
Everyone lies to his neighbor; their flattering lips speak with deception.
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Psalm 38:12
Those who seek my life set their traps, those who would harm me talk of
my ruin; all day long they plot deception.
Jeremiah 9:6
You live in the midst of deception; in their deceit they refuse to
acknowledge me," declares the LORD.
Hosea 10:13
But you have planted wickedness, you have reaped evil, you have eaten
the fruit of deception. Because you have depended on your own strength
and on your many warriors,
2 Corinthians 4:2
Rather, we have renounced secret and shameful ways; we do not use
deception, nor do we distort the word of God. On the contrary, by setting
forth the truth plainly we commend ourselves to every man's conscience in
the sight of God.
Good gifts
Matthew 7:11
If you, then, though you are evil, know how to give good gifts to your
children, how much more will your Father in heaven give good gifts to
those who ask him!
Do unto others as you would have them do unto you
Luke 6:31
Do to others as you would have them do to you.
Healing and trust
Proverbs 13:17
A wicked messenger falls into trouble, but a trustworthy envoy brings
healing.
Submission to authority
Rom 13:1 Everyone must submit himself to the governing authorities, for
there is no authority except that which God has established. The
authorities that exist have been established by God. 2 Consequently, he
who rebels against the authority is rebelling against what God has
instituted, and those who do so will bring judgment on themselves.NIV
Scientific evidence regarding out of date/expired medications
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Pharmaceutical companies are required to certify that their medications are safe,
stable and efficacious.
After September 29, 1978, pharmaceutical manufacturers in the United States
had to place expiration date on medications as required by the Food and Drug
Administration regulation, Current Good Manufacturing Practice (CGMP) Subpart G
Section 211.1371. The law is to, “…assure that a drug product meets applicable
standards of identity, strength, quality, and purity at the time of use, it shall bear an
expiration date determined by appropriate stability testing described”1. Studies have
confirmed that medications used prior to the expiration date are stable 2-6. Although there
is no evidence that a drug will stop being effective after the expiration date, studies have
demonstrated that expired drugs lose their potency over time7.
Many drugs have excellent bioactivity beyond their expiration dates
The Department of Defense and FDA evaluated the shelf life of 96 different drugs
that were stored in US military facilities. Their data showed that 84% of 1122 lots in their
unopened original containers would be expected to remain stable for an average of 57
months after their original expiration date8. Lyon et al recently expanded upon their
previous Department of Defense work by evaluating the stability of a large number of
medications7. Their report summarizes the extended stability profiles for 122 different
drug products (3,005 different lots). Based on testing and stability assessment, 88% of
the lots were extended at least 1 year beyond their original expiration date for an
average extension of 66 months, but the additional stability period was highly variable.
The authors concluded that many drug products, if properly stored, can be extended
past the expiration date; yet, the stability and quality of extended drug products can only
be assured by periodic testing and systematic evaluation of each lot.
A study by Stark et al showed that captopril, cefoxitin sodium powder for injection
and theophylline tablets stored under both ambient and "stress" (40°C and 75% relative
humidity) remained chemically and physically stable for 1.5-9 years beyond their
expiration dates9. Scholtissek et al showed that amantadine and rimantidine are stable
in ambient conditions for 25 years and are even stable after being boiled 10. Studies
have reported efficacy for eye-drops removed from laminated packaging, left in a light in
room temperature for 6 weeks, oral medications including policosanol5,6, diazepam
rectal gel4.
Pharmacists are required to label prescription bottles with an expiration date
Retail pharmacists, in accordance with the standards of the US Pharmacopoeia
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(USP) , label prescription bottles with a "beyond-use" date which is generally one year
from the date the prescription is filled12,13. In a study of pharmacist responses, most
pharmacists recommended discarding medications within 1-2 years of purchase14.
Adverse events have been reported with expired medications
A PubMed search conducted October 10th, 2008 returned no results for expired
medication/expired drug and death or severe adverse effect.
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However, Frimpter et al reported that a reversible renal tubular injury could be
caused by out dated tetracycline15. Current forms of tetracycline have been
reformulated sot that they do not cause the reversible renal damage reported by
Frimpter et al13.
Not all medications have prolonged stability
Drugs in liquid forms may not be as stable, particularly when frozen13. Any
injectibles that have become cloudy or discolored should be discarded. Intravenous
solutions with dextrose which have yellowed due to carmelization should also be
discarded. Storage in high humidity may interfere with the dissolution characteristics of
some oral formulations13. Epi-pens have been shown to lose their potency after their
expiration date16.
Oral rehydration salt (ORS) packets suitable for cottage industry scale produced
by the International Center for Diarrhoeal Disease Research, Bangladesh were found to
be stable for a period of 8 months. Some of the contents in the ORS packets were
found to have turned a light brown color but this did not affect stability17.
Medications issued to patients and then returned to a pharmacy
There are concerns regarding medications issued to patients then returned to a
pharmacy or given to a practitioner for use for another patient. There can be problems
with the storage conditions (heat and humidity), changing (older or another) medication
from one bottle to another, rough handling (so that parts of tablets have turned to
powder), or outright contamination. Confirmation of drug name, dose, storage condition
and stability is likely to be beyond the scope of a short-term healthcare mission team.
Sample medications
Medication samples represent a means by which pharmaceutical companies can
introduce new medications to physicians and patients. The reason that pharmaceutical
companies provide free sample medications is that as physicians gain experience
prescribing these new sample medications, they will prescribe them more often. In a
recent study of Gynecologists and Obstetricians, 92% thought it proper to accept drug
samples18. Sample medications are thought by practitioners to be a convenient, and a
means of providing free medications to patients who are unable to pay for
medications18.
Medications that are being provided as free samples are often newer
medications19, controlled substances, or broad spectrum antibiotics that are not on the
WHO essential medication list20. Also concerning is the finding that many of the free
sample medications are not packaged in child-safe containers or with inadequate
instructions23. A recent study by Cutrona et al, reported that of the fifteen most
frequently distributed free medication samples, four received new or revised black box
warning, indicating that the medication is not be as safe as thought or can even cause
death20. Many medications have been released for treatment of conditions before their
safety and adverse effect profile is fully understood21. One and a half medications are
withdrawn per year due to severe adverse effects that were not recognized at the time
of release22. With more effective advertising and free sample medications, these drugs
can adversely impact large number of people.
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World Heath Organization (WHO) Guidelines for Drug Donation
International humanitarian organizations, such as the Christian Medical
Commission of the World Council of Churches the International Committee of the Red
Cross began work in the 1980’s to develop guidelines for medication donations. The
WHO has taken the lead in developing standards with the input from the
Churches’ Action for Health of the World Council of Churches, the International Committee of
the Red Cross, the International Federation of Red Cross and Red Crescent Societies,
Médecins Sans Frontières, the Office of the United Nations High Commissioner for Refugees,
OXFAM and the United Nations Children's Fund24.
The core principals outlined in the document guiding donated medications are as
follows:
1. Maximum benefit to the recipient
2. Respect for wishes and authority of the recipient
3. No double standards in quality
4. Effective communication between donor and recipient24
While other portions of the document are of interest to short-term healthcare mission
teams (and will be covered elsewhere), the following two sections are particularly
relevant.
1. No drugs should be donated that have been issued to patients and then returned
to a pharmacy or elsewhere, or were given to health professionals as free
samples.
a. Justification and explanation
Patients return unused drugs to a pharmacy to ensure their safe
disposal; the same applies to drug samples that have been received by health
workers. In most countries it is not allowed to issue such drugs to other
patients, because their quality cannot be guaranteed. For this reason returned
drugs should not be donated either. In addition to quality issues, returned
drugs are very difficult to manage at the receiving end because of broken
packages and the small quantities involved.
2. After arrival in the recipient country all donated drugs should have a remaining
shelf-life of at least one year. An exception may be made for direct donations to
specific health facilities, provided that: the responsible professional at the
receiving end acknowledges that (s)he is aware of the shelf-life; and that the
quantity and remaining shelf-life allow for proper administration prior to
expiration. In all cases it is important that the date of arrival and the expiry dates
of the drugs be communicated to the recipient well in advance.
a. Justification and explanation
In many recipient countries, and especially under emergency
situations, there are logistical problems. Very often the regular drug
distribution system has limited possibilities for immediate distribution. Regular
distribution through different storage levels (e.g. central store, provincial store,
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district hospital) may take six to nine months. This provision especially
prevents the donation of drugs just before their expiry, as in most cases such
drugs would only reach the patient after expiry. It is important that the
recipient official responsible for acceptance of the donation is fully aware of
the quantities of drugs being donated, as overstocking may lead to wastage.
The argument that short-dated products can be donated in the case of acute
emergencies, because they will be used rapidly, is incorrect. In emergency
situations the systems for reception, storage and distribution of drugs are very
often disrupted and overloaded, and many donated drugs tend to accumulate.
Additional exception Besides the possible exception for direct donations
mentioned above, an exception should be made for drugs with a total shelflife of less than two years, in which case at least one-third of the shelf-life
should remain.
Sender Perspective
Before
Senders may apply indirect pressure to team leaders/physician team members to
take donations of medications or equipment. Often these conversations start with, “I
have some ________. Can you use it in _________ (fill in the name of a developing
country)…”. Early explanation of polices (specifically: WHO guidelines and “No junk for
Jesus”) should decrease this problem. There also may a gap in understanding and
expectations. Often 19th and early 20th century paternalistic perceptions of medical
missions predominate in many churches. Moreover, there is often little appreciation as
at health systems within the host country.
Occasional stories of expired medications being used in a host country25,26 can
bolster the view that that expired medications are acceptable. There is also a perception
that something is better than nothing, especially when the situation is perceived as dire.
Senders may balk at paying for new medications which may be very expensive.
Organizations including MAP, King’s Pharmaceutical and Blessings International can
help a team obtain sufficient amount of non-expired medications for a reasonable cost.
Senders have an expectation that team leaders have demonstrated due diligence
when dealing with all aspects of their healthcare mission trip. Most senders will expect
that the healthcare mission team leaders will be knowledgeable about issues of what is
legal and right. If this
During
During the trip, senders expect that the team leaders will use good judgment to
avoid problems for the team and the church. Jesus is to be glorified in what is done.
After
If a team has unexpected problems with expired medications in the country
(medications confiscated, group asked to leave country), then the church will
undoubtedly hold the team leader accountable for the problems.
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Goer Perspective
Before
One of the significant problems for leaders and teams that are geared to
providing clinical care in a remote region, is that of gaining sufficient supplies. Most
short-term healthcare mission teams have limited personal funds and rarely receive
money from outside sources. Friends may offer medications and physicians may have
samples donated by a pharmaceutical company that have not been used. Given the
limited resources available to the team, the offer of free medications can be tempting.
Once acquired, however, sorting and removing unnecessary packaging can be time
consuming. If all expired medications are extracted from the pool of donated
medications, there are questions as to how to dispose of the medications in a safe way
such that the medications do not end-up in landfills or the sewer system. Another major
concern regarding donations is the storage conditions of the medications taking into
account keeping them in a location with appropriate humidity and temperature control.
One of the major questions that a team leader will need to address is, “Is more
(medications) better?” What if we had no medications, nothing except God, of course!.
During
When entering a country with expired medications the leader and team may
experience anxiety about being caught with expired/outdated medications.
Example: During our first team trip to Eastern Europe we were carrying expired
medications and non-expired medications for distribution to orphanages and state-run
facilities for street children. Because of anxiety about getting the medications through
customs, the team spread the risk by dividing the medications to all team members.
Bribes to the custom officials were used to ensure that expired medications could enter
the country without problems. We were told to “pray” when going through customs.
Some team leaders and the team members are left with a sense of guilt even if
the medications are successfully brought into the country. Rarely teams have their
outdated medications confiscated..
Often the remaining donated medications, which are not used during the “clinic”,
are the ones that are rarely used in clinical practice in the United States; thus they pose
a “dumping” problem when the team wants to leave the remaining medications in the
host country.
After
Some team members will have long-term guilt and concern about the deception
required to prescribed expired medications.
Recipient Perspective
Before
People and Church
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If there is knowledge that a short-term healthcare mission team is coming to a
particular location, the people may have pre-conceived notions. There may be an
assumption that there is a high correlation between medical missionaries and high
efficacy healing. Basically stated, there are high expectations and a high level of
inherent trust.
Government
More countries are looking to prosecute individuals who are selling or donating
expired medications. Two of the more recent expired medication “busts” to make the
headlines were in Tanzania27 and Bangladesh28. Poor relations with the sending country
could make the expulsion of a short term healthcare missions team due to expired
medications more attractive.
Partner
Partners may expressed concerns about teams bringing medications into the
country and may counsel the team not to bring medications. Problems at the airport
custom area can cause problems for the host partner.
During
People and Church
Most medications distributed to patients are not in their original container so it
can be difficult to determine whether a medication is being given after an expiration
date. If an expired medication is administered, would the person understand issues
related to the lack of efficacy? Any discussion like this could easily erode trust. What
would happen if they found out that the team believes in a double standard in quality
where non-expired medications for the foreigner’s children but outdated medications are
given to theirs? How does a problem like this impact the love that brothers and sisters in
Christ should have for each other.
Partner
The use of expired medications can impact the perception of a team. Questions
like, “If they were willing to cut corners on medications, what else have they done?” may
arise.
Local physicians
Many local physicians look to the international experts to see what they do. The
use of expired medications may send the message that dispensing such medications is
acceptable. Alternatively, should they determine that a double standard is being
employed, the relationship can be impacted.
After
If the recipient perceived that they are receiving something that is of lower quality
than the team member would accept, then there is likely to be a sense of betrayal which
can impede the ability of our partner to be effective in our sharing of the Gospel.
Conclusion
The heart of this discussion is whether or not we, as followers of Christ, ascribe
to double standards. If we accept the concept of double standards, how do we decide
who receives the inferior care? Is it based on a person’s skin color? Their knowledge?
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Their ability to pay? Or is it someone who lives very far away – someone who we will
never see again?
Jesus, addressed this issue head on, when he said in Luke 6:31 Do to others as
you would have them do to you. As Christian healthcare providers we need to provide
our patients with the very best that we can. Doing all that we can allows our patients to
see what God’s Kingdom is like. Additionally we get the benefit of living in peace – and
sleeping at night.
Example: I recently was quite ill while teaching in a small town in China. As my friends
raced me to the Emergency Room for treatment the thought never occurred to me that
the people in the little emergency department would treat me any differently than I
would treat them in our Emergency Room back home. There are hospitals around the
world that have expired medications on their shelves. How would my perception of my
healers changed if I knew that they were giving me out-of date (intravenous)
medications?
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